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Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators (2019)

Chapter: 2 The Job of Medicines Regulators in Today's World

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Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
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Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 22
Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 23
Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 24
Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 25
Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 26
Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 27
Suggested Citation:"2 The Job of Medicines Regulators in Today's World." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 28

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2 The Job of Medicines Regulators in Today’s World Ensuring the health of the public through safe and effective medicines is arguably the highest priority of a medicines regulator. Carrying out this function within an increasingly complex system of production and manufacturing alongside rapidly evolving technology and innovations in medicines, creates a whole new set of challenges and opportunities for regulators. Collaborating with others facing similar issues can be viewed as one way of managing the increasing workload faced by virtually all regulatory authorities (RAs). The key is to understand how cooperation might build coalitions by leveraging finite resources to maximize the assets of each RA. Before delving into various aspects of cooperation for the regulation of medicines, it is important to understand some of the core functions of regulatory authorities and the environment in which they now work, one that has seen unprecedented changes due primarily to advances in technology and applications stemming from the genome project (Wilson and Nicholls, 2015). CORE FUNCTIONS OF REGULATORS AND REGULATORY AUTHORITIES According to World Health Organization’s (WHO) (2002) multi-country study on effective drug regulation, the basis for regulation of medicines resides in a country’s drug laws. It is up to the regulators to implement those laws—that are influenced by new developments and societal needs—by overseeing industry in the use of standards and guidelines. Key functions of regulators include, “licensing, inspection of manufacturing facilities and distribution channels, product assessment and registration, adverse drug reaction (ADR) monitoring, quality control, control of drug promotion and advertising, and control of clinical drug trials” (Ratanawijitrasin et al., 2002). At times, all of these functions are run under one single agency while in other instances the responsibly falls on multiple agencies possibly at differing levels of government which can create fragmentation and decrease the effectiveness of the regulation. Some regulatory authorities are given functions like drug manufacturing and procurement that would be viewed as conflicts of interest to the agency’s mission of drug regulation. This speaks to the issue of financing. Most regulatory authorities are financed through a mix of government support and user-fees, while a small number of regulatory authorities are entirely dependent upon user fees. The financial structure of an agency, according to the WHO report, should not influence PREPUBLICATION COPY: UNCORRECTED PROOFS 19

20 REGULATING MEDICINES IN A GLOBALIZED WORLD regulatory decisions; however, regulatory authorities with inadequate staff, poor working conditions, or poor financing may be subject to compromise (Babigumira et al., 2018). REGULATORS WORKING TOGETHER Most, if not all, well- and moderately well-resourced regulatory authorities have shifted to a risk-based approach to regulation. For each of them, this includes allocating regulatory resources more proportionately so that, for example, manufacturers of medicines with greater risk are inspected more frequently than those that present a much lower risk. The approach also includes working together with other regulatory authorities. Those with similar structures, functions, and national characteristics might find a more natural fit for work together depending upon the collaborative activity undertaken. Such activities can be divided into pre- and post- marketing efforts (Babigumira et al., 2018). Pre-marketing activities as outlined in United States Agency for International Development’s (USAID) (2018) Risk-Based Resource Allocation Framework, include licensing of premises and persons, inspection, evaluation and registration, and quality control testing. Quality control testing can also can also occur post-marketing along with product quality monitoring and surveillance, safety/pharmacovigilance, and enforcement of pharmaceutical laws and regulations. Good Regulatory Practices for Cooperation The Organisation for Economic Co-operation and Development (OECD) (OECD, 2014) described good regulatory outcomes as “almost always a cooperative effort: by the regulator and other regulators, the regulated, and often the broader community.” Moreover, they noted, governance arrangements can foster cooperative efforts. OECD outlined areas of good governance for regulators that could lay a foundation for strong cooperation and collaboration. Six of these areas include: 1. Role clarity – and functions are clear and without conflicts 2. Preventing undue influence and maintaining trust – objective, impartial, consistent, decision making 3. Accountability and transparency – accountable to government and the public 4. Engagement – enhance and maintain public and stakeholder confidence 5. Funding – protect independence but be transparent to heighten confidence in decisions 6. Performance Evaluation – understand impacts of own actions and to drive improvements WHO is developing good regulatory practices guidelines for regulatory authorities specific to medicines. While this and another WHO effort on good reliance practices remain works in progress, there does appear to be potential overlap between the two concepts whereby good regulatory practice involves reliance. In WHO’s (2016a) draft of good regulatory practices guidelines, it states that, “regulations should include sufficient administrative flexibility to allow for participation in international cooperation frameworks, such as for information sharing, convergence, harmonization, work-sharing, reliance and recognition.” PREPUBLICATION COPY: UNCORRECTED PROOFS

THE JOB OF MEDICINES REGULATORS IN TODAY’S WORLD 21 RECOGNITION AND RELIANCE The (WHO, 2016) as part of its benchmarking tool, defined recognition as the routine acceptance of another regulatory authority’s—or other trusted institution’s—regulatory decisions based on the work products of that other agency. In contrast, reliance was defined as more flexible, giving a regulatory authority in one jurisdiction the option of taking into account work products (e.g., inspection reports, scientific assessment reports, joint assessment reports conducted together with another regulatory authority) of another authority or trusted institution, in reaching its own decision. These definitions are noted in Box 2-1. A decision to routinely accept or to take into account the work of another regulator is the choice of the reliant regulatory authority and might be based on a variety of factors including the context in which a decision is being made, access to resources, and whether there is sufficient trust and confidence in the regulatory authority being relied on for information. But regardless of whether a regulatory authority uses recognition or reliance, in the end, it is the responsibly of the regulatory authority to protect the health of its people and thus make the best regulatory decisions for its country. In this regard (shown pictorially in Figure 2-1), recognition can be viewed as a subset, or a more stringent form of reliance, with the mutual recognition agreements as the most stringent form of reliance. BOX 2-1 World Health Organization (WHO) Definitions of Recognition and Reliance Recognition – The routine acceptance [of work products] by the regulatory authority (RA) in one jurisdiction of the regulatory decision of another RA or other trusted institution. Recognition indicates that evidence of conformity with the regulatory requirements of country A is sufficient to meet the regulatory requirements of country B. Recognition may be unilateral, bilateral, or multilateral, although recognition is usual manifest as the subject of mutual recognition agreement. Reliance – The act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to – i.e. totally or partially rely upon work products by another regulatory authority or trusted institution in reaching its own decision. The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others. NOTE: the committee used the term “work product” to better describe the full spectrum of GxP products of regulatory authorities SOURCE: (WHO, 2018b) PREPUBLICATION COPY: UNCORRECTED PROOFS

22 REGULATING MEDICINES IN A GLOBALIZED WORLD FIGURE 2-1 Recognition as a subset of reliance. SOURCES: Adapted from figure created by Dr. Petra Doerr, Swissmedic and presented by Emer Cooke, WHO (WHO, 2019i). The way in which regulatory authorities view recognition and reliance may have more to do with how well-resourced an agency is in relation to another regulatory authority. For example, equally well-resourced authorities would typically take a horizontal perspective in sharing information versus the more unidirectional approach that would likely result from a lower-resourced regulatory authority relying on the work of well-resourced or moderately well- resourced regulatory authorities. These concepts are explained in greater detail below. Recognition and Reliance Among Well-Resourced RAs In the case of recognition and reliance between well-resourced authorities, it is necessary that technical regulatory requirements as well as procedures in inspection/review of medicines manufacturers are fairly close, if not identical. If a good manufacturing practice, itself is different between Country A and Country B, joint inspections, no matter how many times they may be conducted, cannot facilitate reliance regarding the inspection results. Because authorities involved in horizontal recognition and reliance are of similar or comparable capacities, the collaboration is usually mutual and “trust” here means that one agency has evaluated that the other agency does as good a job as their own reviewers or inspectors. Recognition and Reliance with Lower Resourced RAs A lower-resourced authority can base its decision on the work product of well- resourced, trusted authorities. The extent to which the reliance occurs can vary from critically examining the inspection report or review and potentially reaching a different conclusion, to accepting other agencies’ decision without further examination. This type of recognition and reliance would not typically be considered mutual. Regulations need not be completely harmonized between the relying authority and the relied on authority. The “trust” here is from PREPUBLICATION COPY: UNCORRECTED PROOFS

THE JOB OF MEDICINES REGULATORS IN TODAY’S WORLD 23 lower-resourced authorities to well-resourced or moderately well- resourced authorities and can be formed without such critical examination of the capabilities as necessitated for horizontal reliance and recognition, and can be reputation-based, naturally because of the resource constraint. Such recognition and reliance applies to regulatory oversight during pre- and post- approval phases. An example is the Caribbean Regulatory System (CRS) where numerous small states make up the CARICOM/Caribbean Community. Each state lacks the necessary resources and capacity to fully conduct medicines regulation on its own so the CRS uses a regional reliance mechanism—relying on trusted regulatory authorities within PAHO, the European Union (EU) and WHO prequalification—to help inform its decisions about which medicines to recommend for regional market authorization (PAHO, 2019a). Trust as a Foundational Element What underlies all recognition and reliance arrangements is trust. Medicines regulatory authorities cannot rely if they do not trust the provenance and findings of another regulatory authority. This means there are necessary early steps in building trust that, over time, can grow stronger through the use of common international standards (harmonization) and report formats, and through working together. Figure 2-2 illustrates trust in the regulatory sense and how it forms the backbone of any reliance process. Prior to executing formal reliance arrangements, regulatory authorities will likely need to pilot an established process of joint inspections/working together and even auditing of each other’s work. All of these efforts build confidence in the systems and procedures of the respective regulatory authorities. In contrast, other forms of reliance exist that take a more unidirectional approach to the medicines approval process by fully embracing the results of trusted regulatory authorities. PREPUBLICATION COPY: UNCORRECTED PROOFS

24 REGULATING MEDICINES IN A GLOBALIZED WORLD FIGURE 2-2 Trust components needed for reliance. NOTE: RA – regulatory authority; PIC/S = Pharmaceutical Inspection Co-operation Scheme; WHO = World Health Organization. COOPERATION AND COLLABORATION TOOLS OF REGULATORY AUTHORITIES Different tools are available for recognition and reliance across the product lifecycle. These are collectively referred to in this report as “arrangements.” Arrangements can be formal agreements put in place, for example, through memoranda of understanding, confidentiality commitments, and mutual recognition agreements; they can be informal through the establishment of ad hoc committees, working parties and other, more topic specific working groups (EMA, 2019g). In WHO’s draft guidelines for good regulatory practices it is noted that “less formal practices include sharing of information, scientific collaboration, common risk assessment, joint reviews, and development of standards.” Some formal collaborative activities have what might be considered less formal interactions through regularly scheduled calls and meetings that build trust between regulators as they move toward greater confidence levels for reliance. In many cases, pilot activities can be set up under the formal mechanism of confidential arrangements (also known as confidentiality commitments) between regulatory authorities. Each arrangement differs but generally speaking, they allow regulators to exchange confidential PREPUBLICATION COPY: UNCORRECTED PROOFS

THE JOB OF MEDICINES REGULATORS IN TODAY’S WORLD 25 information that is not in the public domain. Pilots can be useful tools for building trust and confidence between regulators from different jurisdictions. One example is the International Generic Drug Regulators Pilot (IGDRP) that began in 2012 as a collaborative arrangement with regulatory authorities from the European Union (EU), Australia, Canada, Chinese Taipei, and Switzerland (EMA, 2015). It was modeled on the EU system that is itself an example of how a network of 50 regulatory authorities from 31 countries (28 Member States, Iceland, Liechtenstein, and Norway) rely on each other through application of the mutual recognition principle, common regulations and procedures. Another example of a work-sharing arrangement (described in Box 2-2) is the Australia, Canada, Switzerland, Singapore (ACSS) Consortium. It started in 2007 as a pilot to maximize international cooperation and it is now exploring opportunities for information-sharing and work-sharing in areas such as: • generic medicines registration • assessment reports for new prescription medicines • information-sharing and investigations into post-market medicine safety • alignment of IT systems for information-sharing • development of technical guidelines (TGA, 2019b). BOX 2-2 Work Sharing: Australia, Canada, Switzerland, Singapore (ACSS) Consortium The ACSS Consortium is a collaborative initiative of like-minded medium-sized regulatory authorities (Australia’s Therapeutic Goods Administration [TGA], Health Canada [HC], Singapore's Health Sciences Authority [HSA], and the Swiss Agency for Therapeutic Products [Swissmedic]) that collaborate during the marketing authorization review of new drugs. Regulatory authorities face similar challenges, such as increasing workload and the increasing complexity of the medicinal applications being regulated, which contribute to increasing pressure on available resources. The purpose of this consortium is to build synergies and share knowledge among these four regulatory authorities, thereby enhancing the efficiency of their individual regulatory system. Work sharing in the marketing authorization of new medicines is one of the inititatives of the ACSS Consortium. Apalutamide (Erlyand®, Erleada®) was the first medicine registered that had been evaluated under the ACSS Consortium’s New Chemical Entities (NCE) Work Sharing initiative. The review also utilized TGA’s new priority review pathway. Memorandum of Understanding (MOU) is another tool frequently used by regulatory authorities to coordinate activities and share information. They are non-binding agreements that can have great variability in their scope depending upon the purpose of the MOU and the parties involved. Often, MOUs allow regulatory authorities a more formal route to clarifying roles and responsibilities of the parties involved. Memorandum of Cooperation (MOC) is similar to an MOU in that it is not legally binding and has been used by Japan to set guidelines for cooperation between parties. Unlike MOUs and MOCs, recognition agreements can be legally binding. PREPUBLICATION COPY: UNCORRECTED PROOFS

26 REGULATING MEDICINES IN A GLOBALIZED WORLD Mutual Recognition Agreements While reliance arrangements promote the sharing of information and facilitate fewer redundant inspections and other regulatory activities, MRAs allow agencies not just to rely on each other’s work products but also to recognize them as equal to the work of their own reviewers or inspectors. For the European Union (EU), MRAs allow for reliance on the GMP inspection systems of other regulatory authorities; information-sharing based on inspections and quality; and the waiving of batch testing of those products imported into EU territories. It should be noted that while safeguarding the public’s health is an intrinsic part of MRAs, they are in the end “trade agreements that aim to facilitate market access” (EMA, 2019c). As such, MRAs tend to be laborious to develop and negotiate, and are labor-intensive to maintain; however, the required preparation and maintenance work is often deemed worthwhile as it prevents duplication of effort, makes precious resources available, and expedites approval time and market release, all of which are of great public health benefit. As is shown in later chapters of this report, these benefits are also achieved through the use of reliance arrangements that do not pose many of the challenges associated with MRAs. See Appendix B for a list of the MRAs that are a primary focus of this report. Unilateral and Multilateral Recognition Unilateral recognition allow one regulatory authority’s decisions to be informed partially or fully by the work of another regulatory authority. Some Latin American countries take such an approach. One example is Mexico’s regulatory authority, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), that in 2012, set up a unilateral agreement with the European Union (EU) to use work carried out at the EMA during their single marketing authorization process (WHO, 2016d). COFEPRIS set up other similar unilateral processes with the U.S. FDA, Health Canada, TGA, and Swissmedic to expedite the approval and entry of new medicines onto the Mexican market (Patel et al., 2019). It appears that other Latin American countries (i.e., Dominican Republic, Argentina, Ecuador, Peru, Paraguay, Uruguay, and El Salvador) may also use unilateral approaches based on information from what the countries deem as trusted sources (Sravani et al., 2017). With this set up, those countries that are relied upon are placed in a position whereby approval decisions in their jurisdiction have relevance and impacts outside of their own country or region. There is also multilateral recognition, such as those seen with the European Economic Area (EEA) that unites the EU Member States with Iceland, Liechtenstein, and Norway (Association, 2019) and others (New Zealand, Australia, Canada, and Switzerland) for the purposes of recognizing good manufacturing practices and additionally, good laboratory practice in the MRA between EEA and Switzerland. Another example are the mutual recognition arrangements of the Association of Southeast Asian Nations (ASEAN) member states. In this case, all ASEAN member states are “obliged to recognize and accept the [GMP] inspection reports and certificates issued by ASEAN Inspection Services without duplicating GMP inspection in each other’s territory” (HSA). The Mexican regulator COFEPRIS also has multilateral agreements with a number of regional and international organizations, each with different scopes for different conformity assessment bodies (Acreditación, 2019). PREPUBLICATION COPY: UNCORRECTED PROOFS

THE JOB OF MEDICINES REGULATORS IN TODAY’S WORLD 27 Cooperation Through Harmonization Broader efforts among countries for cooperation on aspects of the regulation of medicines have taken place under the auspices of regulatory harmonization (APEC, 2019; ICH, 2019; IPRP, 2019; PAHO, 2019b). Regulatory reliance may be facilitated by having regulatory authorities converge more than diverge on procedures, common formats for reports, forms, and soon as appropriate and as supported by international organizations such as ICH, and by bringing regulators together for various collaborative and cooperative efforts (see Box 2-3 for a summary of harmonization, convergence and reliance efforts through international organizations). BOX 2-3 Representative Multilateral International Cooperative and Collaborative Efforts in Pharmaceutical Regulation • International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): ICH brings together the major regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved to respond to the increasingly global nature of drug development by preparing numerous harmonized technical requirements for authorization and regulatory oversight of pharmaceuticals for human use.* • International Pharmaceutical Regulators Program (IPRP): IPRP was created to establish a forum for its regulatory members and observers to exchange information on issues of mutual interest and enable regulatory cooperation. This venue assists in maximising potential efficiencies in addressing the increasingly complex global regulatory environment, facilitates the implementation of ICH and other internationally harmonised technical guidelines for pharmaceuticals for human use, promotes collaboration and regulatory convergence, and contributes to the coordination of international efforts related to regulation of medicinal products for human use. • International Coalition of Medicines Regulatory Authorities (ICMRA): ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to address current and emerging human medicine regulatory and safety challenges globally, provide direction for areas and activities common to many regulatory authorities' missions, identify areas for potential synergies and wherever possible, leverage existing initiatives/enablers and resources. ICMRA will provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues. • International Conference of Drug Regulatory Authorities (ICDRA): The conferences have been held since 1980 to provide drug regulatory authorities of all 194 WHO Member States with a forum to meet and discuss priorities for action in national and international regulation of medicines, vaccines, biomedicines and herbals. ICDRA’s aim is to promote exchange of information and collaborative approaches to issues of common concern, find ways to strengthen collaboration and serve as tool for WHO and drug regulatory authorities in their efforts to harmonise regulation and improve the safety, efficacy and quality of medicines. • Pharmaceutical Inspection Co-operation Scheme (PIC/S): PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of PREPUBLICATION COPY: UNCORRECTED PROOFS

28 REGULATING MEDICINES IN A GLOBALIZED WORLD Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It has 52 participating authorities and is open to any Authority having a comparable GMP inspection system aiming at harmonising inspection procedures and standards, facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. • Australia, Canada, Singapore, Switzerland Consortium (ACSS Consortium): The ACSS Consortium is a coalition, which was formed in 2007 by “like-minded” regulatory authorities to promote information and work-sharing. Its goal is to reduce duplication, and increase each agency's capacity to ensure consumers have timely access to high-quality, safe, and effective therapeutic products. _____________________ *NOTE: Veterinary ICH (VICH) also exists, but it is a different organization with its secretariat role fulfilled by HealthforAnimals. VICH is a trilateral ([EU]–Japan-US) program, involving several observer organizations, aimed at harmonizing technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. VICH was officially launched in April 1996. Strengthening Regulatory Systems for Medicines Through Transparency Regulatory authorities in low- and middle-income countries face multiple challenges that vary by country. According to Roth et al. (2018), these challenges tend to include access to medicines—in part due to limited commercial returns for industry—as well as access to evidence-based data both pre- and post-market. Efforts have been made in some instances to improve the supply of medicines in developing countries by donor organizations, the pharmaceutical industry, and public private partnerships, although despite the efforts, a lag-time persists. Typically, it takes 4 to 7 years between the initial approval by one regulatory authority (generally in a developed country) and the final approval (in the developing country) (Ahonkhai et al., 2016). Numerous reasons were suggested as to the cause of the delay that included a “failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries.” There are some efforts underway to build regulatory capacity for accelerated registration through WHO prequalification (WHO, 2019e) and the work of ICMRA in the area of GMP (ICMRA, 2017). As capacity is built within some regulatory authorities to better utilize information from trusted authorities, fuller access to information, reports, and data will likely become more valuable. In an effort to promote greater openness and transparency, WHO, EMA, and U.S. FDA have sought to make some information publically available (EMA, 2019h; FDA, 2015; WHO, 2019f). These reports exclude confidential proprietary information and, in the case of WHO, are only posted on their website with the manufacturer’s approval. Similarly, openness between well-resourced regulatory authorities and lower-resourced regulatory authorities would almost certainly require input from industry. PREPUBLICATION COPY: UNCORRECTED PROOFS

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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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